Envarsus in Delayed Graft Function (E-DGF)

NCT03864926 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: 2018-0530A534280SMPH/MEDICINE/NEPHROLOGY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.

Conditions

Delayed Graft Function

Keywords

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Number of Days Needed to Recover From Delayed Graft Function (DGF)

  The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).

  up to 3 months post transplant

Secondary Outcomes (1)

• Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF

  up to 3 months post transplant

Other Outcomes (1)

• Number of Participants Experiencing Related Adverse Events

  up to 3 months post transplant

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of Care Tacrolimus

Drug: Tacrolimus

Experimental

EXPERIMENTAL

Envarsus XR

Drug: Envarsus XR

Interventions

Envarsus XR DRUG

Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day. Envarsus XR, a calcineurin-inhibitor immunosuppressant, is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. Tacrolimus is the active ingredient in ENVARSUS XR.

Experimental

Tacrolimus DRUG

Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, at least 18 years of age
• Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant
• Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen
• Females of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

You may not qualify if:

• History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
• Current use of non-tacrolimus based immunosuppressive regimen or no plan to start tacrolimus based regimen
• Women who are or plan to become pregnant or breast-feeding during the study period
• Not suitable for study participation due to other reasons at the discretion of the investigator
• Major post-surgical complications requiring allograft nephrectomy
• Multi-organ transplant recipients
• Non kidney transplant recipients

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Veloxis Pharmaceuticals: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Parajuli S, Bloom M, Mandelbrot D, Astor BC. Serum beta2-Microglobulin Predicts Time to Recovery of Delayed Graft Function in Kidney Transplant Recipients. Clin Transplant. 2024 Aug;38(8):e15435. doi: 10.1111/ctr.15435.

  PMID: 39158946 DERIVED

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Sandesh Parajuli, MD, MBBS
• Organization: University of Wisconsin Hospital and Clinics

sparajuli@medicine.wisc.edu

(608) 265-0152

Study Officials

• Sandesh Parajuli, MBBS

  University of Wisconsin School of Medicine and Public Health, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 6, 2019
• Study Start: March 18, 2019
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: July 20, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-05

Locations

US (1)